Sr. Engineer / Operations Integrator - Añasco

Descripción del Empleo:
Creating, characterizing and implementing new process or process improvements required for NPD. Develop operational strategies to manage complex manufacturing process design, development and validation efforts. Lead Ops Integration efforts to complete deliverables necessary for NPD and integration into existing operations. Work and effectively communicate in a high energy, cross functional team and multiple site environment which includes product design, regulatory, quality, procurement, configuration management, supply chain, supplier quality and operations to ensure project objectives are met. Drive incorporation of technical advancements into manufacturing process and technology employed in the manufacture of both existing and new products. Continuously improve existing materials, manufacturability and sustainability. Be the subject matter expert.
Requisitos:
Minimum of six years of experience (with bachelor's degree) or four years of experience (with Master’s Degree) in the medical device industry with key technologies and processes related to the assembly and manufacture of Class II or III cardiovascular devices. Degree in Mechanical, Electrical, Materials, Chemical, or Biomedical Engineering. Demonstrated use of process excellence methodologies and applied statistics. Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN experience leading to manufacturing efficiency improvement. Effective knowledge transfer experience. Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation. Capable of analyzing and solving complex problems through innovative thought and experience. Demonstrated strong project management skills leading to cost savings. Strong communication.